NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002— 510(k) K060336
Substantially EquivalentOrthosoft, Inc.
FDA 510(k) clearance K060336 for NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002, Substantially Equivalent on 2006-04-28. Applicant: Orthosoft, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthosoft, Inc.
- Product code
- Code HAW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Montreal, CA
Recent devices under product code HAW
view allMore clearances from Orthosoft, Inc.
view all- K131409 — CAS PSI KNEE SYSTEM
- K100599 — CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
- K071929 — NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL
- K071714 — NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003
- K043536 — NAVITRACK SYSTEM - S&N IMAGE FREE KNEE
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K060336
K-number listed on FDA's recall record- Z-2076-2017 — Navitrack System - OS Knee Universal, Stereotaxic instrument
- Z-2075-2017 — Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060336.
Data sourced from openFDA. This site is unofficial and independent of the FDA.